Abstract

Objective: The overall purpose of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC. Structure and services: The overall goal of QA and DSM for the University of Colorado Cancer Center (UCCC) remains twofold: 1) insure the safety and ethical treatment of all human subjects participating in research;2) verify the accuracy, completeness, validity and integrity of all data_collected. Multiple committees and processes contribute to the achievement of these goals. UCCC Protocol Quality Assurance and Safety Committee (PQASC) oversees all aspects of the process within the UCCC Clinical Investigations Core Shared Resource (CICSR) and reports to the Executive Committee of the UCCC, and to COMIRB;and oversees reporting of AEs and SAEs to sponsors and federal agencies, e.g., NCI AdEERs. Collaborative efforts to improve the efficiency and accuracy of the clinical trials process at UC Anschutz Medical Campus (AMC) and UCCC continue through UCCC CICSR interactions with COMIRB including the Director of COMIRB (Alison Lakin, RN, PhD), the Associate Vice Chancellor for Compliance (Angela Wishon, JD) and other groups such as the School of Medicine Clinical Trials Research Advisory Committee (CTRAC) and importantly the protocol review and monitoring committee (PRMC) of the UCCC. These collaborations have contributed to the successful CTSA application in 2008 (Colorado Clinical Translational Sciences Institute). The CICSR Education Committee identifies develops and offers a variety of instructional activities to improve the l The aims of the education activities are to insure high quality conduct and analysis of clinical trials and the specific objectives remain as presented in the Competing Renewal. Four subcommittees provide the needed training: oversight continuing education, orientation and competency Utilization: All UCCC human subject research is subject to oversight by this core. Audits of selected trials, especially investigator-Initiated, are conducted periodically, and the PQASC of this core also provides a data safety monitoring board (DSMB) for trials which do not have a designated DSMB.

Public Health Relevance

At the University of Colorado Cancer Center (UCCC) we take patient research (clinical trials) safety very seriously. We have specific body called the Quality Assurance (QA) / Data Safety Monitoring (DSM)for this purpose. The mission of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC grant applications or industry.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA046934-26
Application #
8616651
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-02-01
Budget End
2015-01-31
Support Year
26
Fiscal Year
2014
Total Cost
$60,711
Indirect Cost
$22,136

  Institution

Name
University of Colorado Denver
Department
Type
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045

  Publications

Maccini, Michael A; Westfall, Nicholas J; Van Bokhoven, Adrie et al. (2018) The effect of digital rectal exam on the 4Kscore for aggressive prostate cancer. Prostate 78:506-511
Ye, Haobin; Adane, Biniam; Khan, Nabilah et al. (2018) Subversion of Systemic Glucose Metabolism as a Mechanism to Support the Growth of Leukemia Cells. Cancer Cell 34:659-673.e6
Flannery, Patrick C; DeSisto, John A; Amani, Vladimir et al. (2018) Preclinical analysis of MTOR complex 1/2 inhibition in diffuse intrinsic pontine glioma. Oncol Rep 39:455-464
Elder, Alan M; Tamburini, Beth A J; Crump, Lyndsey S et al. (2018) Semaphorin 7A Promotes Macrophage-Mediated Lymphatic Remodeling during Postpartum Mammary Gland Involution and in Breast Cancer. Cancer Res 78:6473-6485
Yue, Zongliang; Zheng, Qi; Neylon, Michael T et al. (2018) PAGER 2.0: an update to the pathway, annotated-list and gene-signature electronic repository for Human Network Biology. Nucleic Acids Res 46:D668-D676
Smith, Weston J; Tran, Huy; Griffin, James I et al. (2018) Lipophilic indocarbocyanine conjugates for efficient incorporation of enzymes, antibodies and small molecules into biological membranes. Biomaterials 161:57-68
Morgan, Michael J; Fitzwalter, Brent E; Owens, Charles R et al. (2018) Metastatic cells are preferentially vulnerable to lysosomal inhibition. Proc Natl Acad Sci U S A 115:E8479-E8488
Hartwick, Erik W; Costantino, David A; MacFadden, Andrea et al. (2018) Ribosome-induced RNA conformational changes in a viral 3'-UTR sense and regulate translation levels. Nat Commun 9:5074
Genova, Carlo; Socinski, Mark A; Hozak, Rebecca R et al. (2018) EGFR Gene Copy Number by FISH May Predict Outcome of Necitumumab in Squamous Lung Carcinomas: Analysis from the SQUIRE Study. J Thorac Oncol 13:228-236
Greer, Robert O; Eskendri, Jeffrey; Freedman, Paul et al. (2018) Assessment of biologically aggressive, recurrent glandular odontogenic cysts for mastermind-like 2 (MAML2) rearrangements: histopathologic and fluorescent in situ hybridization (FISH) findings in 11 cases. J Oral Pathol Med 47:192-197

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